Recall Z-1194-2018— Arrow International Inc
Class II · Terminated
Class II FDA medical device recall by Arrow International Inc, initiated 2017-12-15, terminated 2019-07-18. It names one FDA 510(k) clearance: K151513. Product: ARROW ENDURANCE" Extended Dwell Peripheral Catheter System, Catalog Numbers: EDC-00820 & EDC-00820-B. Reason: Certain lots of peripheral catheter systems may be missing the safety latch, intended to minimize the risk of sharps injuries..
- Recalling firm
- Arrow International Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-12-15
- Terminated
- 2019-07-18
- Firm location
- Reading, PA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
ARROW ENDURANCE" Extended Dwell Peripheral Catheter System, Catalog Numbers: EDC-00820 & EDC-00820-B
Reason for recall
Certain lots of peripheral catheter systems may be missing the safety latch, intended to minimize the risk of sharps injuries.
Data sourced from openFDA. This site is unofficial and independent of the FDA.